Preoperative Folfirinox, Radiation Therapy for Resectable Adenocarcinoma of the Pancreas

PHASE2CompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

June 14, 2012

Primary Completion Date

February 20, 2019

Study Completion Date

February 20, 2019

Conditions
Pancreatic Cancer
Interventions
DRUG

Oxaliplatin

75 mg/m2 by vein on Day 1 of weeks 1, 3, 5, 7, 9 and 11 for 12 weeks.

DRUG

Irinotecan

150 mg/m2 by vein on Day 1 of weeks 1, 3, 5, 7, 9 and 11 for 12 weeks.

DRUG

5-FU

2000 mg/m2 by vein over 46 hour continuous infusion, on Days 1 - 2 during weeks 1, 3, 5, 7, 9 and 11 for 12 weeks.

DRUG

Gemcitabine

350 mg/m2 by vein every week for 5 doses beginning Day 1 (days 1, 8, 15, 22, 29).

RADIATION

Radiation Therapy

External beam radiation therapy delivered 5 days/week +/- 2 days over 5.5 weeks with 18-MeV photons. 3D conformal RT, a total dose of 50.4 Gy 1.8 Gy/fraction (28 fractions).

Trial Locations (1)

77030

University of Texas MD Anderson Cancer Center, Houston

All Listed Sponsors
lead

M.D. Anderson Cancer Center

OTHER

NCT01560949 - Preoperative Folfirinox, Radiation Therapy for Resectable Adenocarcinoma of the Pancreas | Biotech Hunter | Biotech Hunter